FDA Registration
Active
🇺🇸 United States
N'Vision Programmer
Reg #: 3003120897
·
FEI: 3003120897
·
Expires 2025
Products
4
Proprietary Names
15
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- MEDTRONIC SOFAMOR DANEK USA, INC.
- Registration Number
- 3003120897
- FEI Number
- 3003120897
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4340 Swinnea Road
- City
- Memphis
- State
- TN
- ZIP
- 38118
- Country
- US
Regulatory Submissions
- PMA Number
- P960009
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Thalamic, Epilepsy, Implanted | MBX | Class 3 | Unknown | No | 2006-01-18 |
| Stimulator, Electrical, Implanted, For Essential Tremor | PJS | Class 3 | Unknown | No | 2006-01-18 |
| Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | NHL | Class 3 | Unknown | No | 2006-01-18 |
| Stimulator, Electrical, Implanted, For Parkinsonian Tremor | MHY | Class 3 | Unknown | No | 2006-01-18 |
Proprietary Names
N'Vision Programmer
Activa PC Neurostimulator
Access Therapy Controller
Activa Parkinsons Control Therapy
Access Review Therapy Controller
StimLoc
Activa RC Neurostimulator
Activa Tremor Control Therapy
DBS Extension Kit
Activa SC Neurostimulator
N'Vision Software Application Card
Intercept
Percept PC BrainSense
SenSight
Percept RC Rechargeable Neurostimulator with BrainSense Technology
Establishment Types
Manufacture Medical Device